Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators

NCT04749121 | Completed DMC

• 1 other identifier: 059/63
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Since the innovation of our new half- elastometric half-piece respirator, this type of FFR has been used widely in our country. Decontamination methods including ultraviolet C (UVC) germicidal irradiation and 70% alcohol have been implemented to decontaminate the respirator. We than examined inactivation potential for the Porcine epidemic diarrhea virus (PEDV), numerous bacterial strains ,mostly skin-derived after the decontamination process.To enable rigorous integrity after repeated decontamination process, fit test by the Bitrex test ,tensile strength and elongation at break were also evaluated. Our results showed that the UVC at the dose of 3 J/cm2 can eradicate the bacteria at 60 min and virus at 10 min.No fungus was found on the mask surface at the beginning. Good Fit test , tensile strength and elongation at break were still main maintained after multiple cycles of decontamination. No evidence of physical degradation by gross visual inspection was found. 70% alcohol is also an easy and effective way to eradicate microorganisms on the mask.As the current pandemic is expected to continue for months to years, the need to supply adequate reserves of PPE and develop effective reprocessing is crucial. Our studies demonstrated that the novel silicone mask can be safely reprocessed and decontaminated for many cycles by UVC irradiation and help restore the shortage of the important protective devices in the COVID-19 pandemic era.

Conditions

Covid19

Keywords

COVID-19; Decontamination; Filtering facepiece respirators; UVC

Outcome Measures

Primary Outcomes (3)

• Fit test

  The percent of participants that passed the fit test after UVC decontamination

  3 days

• Colony count of microorganisms

  Colony count of virus ,bacteria and fungus after UVC and alcohol decontamination

  2 weeks

• Load of Tensile strength

  Measure tensile strength and elengation at break after UVC irradiation (Millipascal)

  2 weeks

Study Arms (1)

Fit test

EXPERIMENTAL

All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes.The protocol was conducted in accordance with the protocol from the OSHA respiratory protection standard , including the number, type, and duration of the exercise, and the seal checks in accordance with the manufacturer's instructions\[15\] 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol)

Device: UVC Irradiation; Drug: UVC Irradiation; Device: Fit test; Device: Tensile strength

Interventions

UVC Irradiation DEVICE

We used the Porcine epidemic diarrhea virus (PEDV) as the indicator virus .An N99 mask was contaminated by spraying or applying with the virus on the exterior and interior surface of each silicone mask. Also, 100 μl of the viral suspension was spotted onto the filter part of N99 masks. Following 20-30 minutes of drying, the silicone masks underwent each of the decontamination procedures which are ultraviolet-C (UV-C) irradiation and 70% alcohol treatment. For UV irradiation, N99 masks were placed in an UV-C incubator ) and were exposed for different times at 1, 10 and 20 minutes, respectively.Untreated control and treated N99 masks were analyzed for viral infectivity in VERO cell cultures. At 48 hours post-infection, cells were examined for evaluation the viral infectivity via observation of cytopathic effect. Results for each treatment express mean ± standard deviations of 3 biological replicates.

Fit test

Fit test DEVICE

All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol),

Fit test

Tensile strength DEVICE

We measured the tensile strength of the strap of the Silicone mask before and after the UVC irradiation to study the strength and reliliency of the strap

Fit test

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers 18 to 60 years old.

You may not qualify if:

• contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Bangkok, 10300, Thailand

Location

Related Links

• 5\. Centers for Disease Control and Prevention. Decontamination and reuse of filtering facepiece respirators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thananda Trakarnvanich

  Bangkok Metropolitan Administration and Vajira Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participants will be tested for fit test before and after UVC determination of the respirators.The other tests were in vitro and based on the survival of bacteria and virus on the masks together with the tensile strength
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Before and after intervention in one group

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 11, 2021
• Study Start: April 1, 2020
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

TH (1)